N/A
N=708
Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice
Chronic Venous Disease
Bottom Line
View on ClinicalTrials.gov: NCT03722836 ↗Enrolled (actual)
708
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 — 53.8; 15.6; 42.4; 11.2 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 |
53.8; 15.6; 42.4; 11.2; 56.8; 13.8 | — |
| PRIMARY Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones. |
289 | — |
| SECONDARY Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 |
41.0; 12.8; 31.6; 11.1; 24.5; 5.7 | — |
Summary
The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900
Eligibility Criteria
Inclusion Criteria
- Age 18 years old or above
- Written informed consent
- Patient did not receive treatment with venoactive drugs within the past 4 weeks prior to the inclusion in the study
- Diagnosis of chronic venous disease of class C3 (CEAP)
- Decision of an attending physician to prescribe Detralex.
Exclusion Criteria
- Age below 18 years old
- Written informed consent is not obtained
- History of alcohol or drug abuse or use of narcotic drugs
- History of allergic reaction to diosmin or any other venoactive agent, or their intolerance
- History of allergic reaction to anesthetics and/or sclerosing agents
- Chronic venous disease of СЕАР class C0-С2 or class С4-С6
- Lymphatic edema of the lower extremities
- Secondary varicose veins, angiodysplasia, or neoplasia
- Arterial disease (ankle-brachial index 30 kg/m2 [BMI = body mass (kg)/height (m)2]
- Predictable poor adherence to treatment
- Participation of the patient in the intervention study within the previous 3 months
- For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study
- Patient cannot attend a follow-up visit
- Patients with a contraindication to diosmin-containing agents, including Detralex
Data sourced from ClinicalTrials.gov (NCT03722836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.